PREPIDIL SUMMARY
Prepidil® Gel dinoprostone cervical gel
PREPIDIL Gel contains dinoprostone as the naturally occurring form of prostaglandin E2 (PGE2) and is designated chemically as (5Z, 11a, 13E, 15S)-11,15-Dihydroxy-9-oxo-prosta-5,13-dien-1-oic acid.
PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction.
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NEWS HIGHLIGHTS
Published Studies Related to Prepidil (Dinoprostone Vaginal)
A randomized clinical trial to compare the efficacy of different doses of intravaginal misoprostol with intracervical dinoprostone for cervical ripening and labor induction. [2011.07] OBJECTIVES: To compare the efficacy of 25 vs. 50 microg of intravaginal misoprostol vs. intracervical dinoprostone for cervical ripening and labor induction... CONCLUSION: Intravaginal misoprostol 50 microg administered 6 hourly appears to be most effective as it has least induction to delivery time, has maximum improvement in Bishop's score, least oxytocin requirement without any increase in complication rate.
Cardiotocographic abnormalities associated with misoprostol and dinoprostone cervical ripening and labor induction. [2011.06] OBJECTIVE: To characterize the incidence and timing of cardiotocographic (CTG) abnormalities associated with misoprostol and dinoprostone vaginal inserts during labor induction... CONCLUSION: Cardiotocographic abnormalities were less frequent and occurred after longer exposure with MVI 50 than MVI 100 or dinoprostone. Clinical outcomes were similar among the groups. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.
[Comparison of isosorbide dinitrate and dinoprostone for induction of labor in term pregnancy]. [2011.05] CONCLUSIONS: the isosorbide dinitrate is associated with lower duration of labor compared with dinoprostone. There was no difference in the maternal-fetal outcome by using whatever drug.
Induction of labor and pain: a randomized trial between two vaginal preparations of dinoprostone in nulliparous women with an unfavorable cervix. [2011.05] OBJECTIVE: To compare pain associated with vaginal dinoprostone pessary vs. gel for induction of labor in women with an unfavorable cervix... CONCLUSIONS: The two induction procedures should be considered equivalent as far as ripening the cervix and initiating labor. In view of this finding, the low Bishop score should be considered an indication to prefer the controlled-release device, since it reduces pain thereby improving the physical and emotional wellbeing of the parturient.
Sustained-release dinoprostone vaginal pessary with concurrent high-dose oxytocin infusion compared to sustained-release dinoprostone vaginal pessary followed 6 h later by high-dose oxytocin infusion for labor induction in women at term with unfavorable cervix: a randomized controlled trial. [2011] OBJECTIVE: To compare the efficacy and safety of sustained-release dinoprostone vaginal pessary and concurrent high-dose oxytocin infusion with sustained-release dinoprostone vaginal pessary followed 6 h later by high-dose oxytocin infusion for cervical ripening and labor induction... CONCLUSION: Sustained-release dinoprostone followed 6 h later by high-dose oxytocin infusion appears to be safer and more effective than sustained-release dinoprostone with concurrent high-dose oxytocin infusion in achieving cervical ripening and successful vaginal delivery. Copyright (c) 2010 S. Karger AG, Basel.
Clinical Trials Related to Prepidil (Dinoprostone Vaginal)
Comparison of Pre-Induction Cervical Ripening [Completed]
This study is designed to assess the effectiveness of a combination method of induction of
labor using a urinary balloon catheter and prostaglandin gel.
The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery
rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed
induction in the United States is rising. This has led to a renewed effort to examine the
effectiveness of the varied methods of induction.
The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel
for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto
Health Richland for a scheduled induction of labor will be offered enrollment in the trial.
Patients who enroll in the study will be randomized into one of 3 study arms: urinary
balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and
prostaglandin gel. Randomization will be per sealed envelope from the locked nurse
medication storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland.
The investigator will be given the next sequentially numbered study randomization envelope
by the patient's nurse. The randomization assignment will be unblinded to the patient and
her physicians. If the patient is not in active labor 6 hours after initiation of the
intervention, a standardized protocol of oxytocin will commence. Labor management will be at
the discretion of the physician.
Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term [Completed]
The purpose of this study is to determine whether induction of labor with vaginal
misoprostol application will result in fewer cesarean deliveries than vaginal PGE2 gel
application in women with premature rupture of membranes at term.
Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery [Completed]
The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200
microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone
Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and
induction of labor.
Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor [Completed]
The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and
100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R)
in women who need to have cervical ripneing and induction of labor.
Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter [Recruiting]
The purpose of this study is to compare the efficacy of single balloon foley catheters to
dinoprostone for the induction of labour of obese women. The investigators suspect that
women assigned to the foley group will have a shorter induction to delivery time than women
in the dinoprostone group.
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